EDF Health

EPA’s just-released methylene chloride draft risk evaluation: Some important context

By / Bio / Published: October 29, 2019

Richard Denison, Ph.D., is a Lead Senior Scientist.

After more than a month’s delay, EPA today released its draft risk evaluation for methylene chloride.  Running to 725 pages (not counting more than a dozen supplemental files), it will take some time to digest.  But here are some initial observations that provide context for those of you who will be looking closer.

First, methylene chloride is a very nasty chemical.  It has killed a lot of people.  It causes cancer.  Short- and long-term exposure to it is tied to liver effects, immune system effects, nervous system effects, and reproductive/developmental effects.

So it shouldn’t be surprising that EPA’s draft – even coming from an administration not known to be overly worried about the risks of chemicals – has found that most industrial, commercial and consumer uses of methylene chloride present unreasonable risks.

For example, EPA found that workers using methylene chloride-based paint strippers face high risks.  Of course, we knew that already:  EPA identified those risks more than five years ago, and proposed to ban those uses.  This EPA decided it had to do it all over again – which means that thousands of workers have continued to be unnecessarily exposed to this deadly chemical.  And it will be even more years before we get back to where we were before EPA took its mulligan.

So the good news is that EPA seems to be acknowledging that methylene chloride presents high enough risks to warrant regulation under the Toxic Substances Control Act (TSCA).

The bad news is that EPA is dramatically underestimating the magnitude of methylene chloride’s risks – by pulling the same tricks it has for other chemicals among the first 10 it is evaluating under TSCA:

  • EPA once again ignores all exposures and risks to the general population by falsely assuming those exposures and risks are eliminated by actions it has taken or could take under other laws. That means ignoring over 4 million pounds of methylene chloride annually released to air, water and land.  See this backgrounder for the details and why this EPA assumption about methylene chloride is deeply flawed.
  • EPA once again grossly understates risks to workers:
    • EPA assumes that workers will always wear fully effective personal protective equipment (respirators and gloves) to make many of the risks it identifies go away – and to grossly understate the magnitude of the unreasonable risks it does find.
    • EPA once again finds a cancer risk to workers unreasonable only if it exceeds a level of 1 in 10,000 – which is 100 times higher a risk than warrants regulation under TSCA to protect workers and other vulnerable subpopulations.
    • For occupational non-users (ONUs), EPA has once again failed to identify unreasonable risks for the most highly exposed, and hence most vulnerable, workers unless it finds that the majority of workers also face unreasonable risks.

These are just a few initial observations based on our reading of EPA’s opus so far.

So while it’s somewhat encouraging that this new draft risk evaluation has found many more risks than previous drafts, we can already tell the draft falls far short of adequately describing the risks presented by methylene chloride.

Stay tuned.

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An unwarranted assumption run amok: How the Trump EPA grossly understates the risks of 1-Bromopropane to workers

By / Bio / Published: October 2, 2019

Richard Denison, Ph.D., is a Lead Senior Scientist.

We have blogged repeatedly about the ways in which the Trump EPA is compromising workers’ health, either by failing to identify the significant risks they face, or wishing away the risks EPA does identify by erroneously assuming that existing industry practices and OSHA regulations are taking care of any possible problem.

If EPA uses PPE assumptions to erase unreasonable risks, then it won’t regulate the chemical and will forgo its only opportunity to ensure that PPE is actually used.  If EPA does find unreasonable risk even with its PPE assumptions, by understating the magnitude of that risk, any subsequent regulation EPA promulgates will be underprotective.

All of this is contrary to the mandate Congress gave EPA when it reformed the Toxic Substances Control Act (TSCA) in 2016.  The new TSCA strengthens EPA’s authority and mandate to protect workers, explicitly identifying them as a “potentially exposed or susceptible subpopulation.”  But under this administration, EPA has instituted many policies and practices that undercut the protections afforded workers under TSCA.

A key policy driver is EPA’s assertion – absent any empirical evidence to support it – that workers throughout chemical supply chains will always wear effective personal protective equipment (PPE).  There are many legal, scientific and policy problems with this assumption, and it is only one of many questionable aspects of the Trump EPA’s handling of risks to workers.

But just how big a difference does this assumption make?  Let’s look at the agency’s draft risk evaluation for the carcinogenic solvent 1-Bromopropane (1-BP), which is currently undergoing public comment and peer review.  Read More »

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Trump EPA caves again to industry demands on new chemicals, and workers pay the price

By / Bio / Published: August 8, 2019

Richard Denison, Ph.D., is a Lead Senior Scientist.

Isocyanates are nasty chemicals, including when they are left over as residuals after manufacturing other chemicals.  Here are the kinds of risks they pose, according to the National Institute for Occupational Safety and Health (NIOSH):

Isocyanates are powerful irritants to the mucous membranes of the eyes and gastrointestinal and respiratory tracts.  Direct skin contact can also cause marked inflammation.  Isocyanates can also sensitize workers, making them subject to severe asthma attacks if they are exposed again. There is evidence that both respiratory and dermal exposures can lead to sensitization.  Death from severe asthma in some sensitized subjects has been reported.

In prior reviews of new chemicals under the Toxic Substances Control Act, EPA has repeatedly indicated that “[i]socyanate exposure has been identified as the leading attributable cause of work-related asthma, and prevalence in the exposed workforce has been estimated at 1-20 percent.”

Both NIOSH and EPA have raised even greater concern over activities involving spray application of chemicals containing isocyanates.  In 2006, NIOSH issued a rare alert calling for workers to undergo medical surveillance and wear high-efficiency respirators and gloves when engaged in such activities.

Even in the recent past, when reviewing new chemicals containing isocyanate residuals, EPA has typically (1) issued a consent order subjecting the company submitting the chemical for review to multiple conditions in order to limit workplace inhalation exposures to the residuals, and (2) followed up with a Significant New Use Rule (SNUR) that extends those conditions to other companies, requiring them to notify EPA prior to engaging in any activity that exceeds those workplace limits.  And the only case since TSCA was amended in 2016 where EPA found a new chemical “presents an unreasonable risk” – as opposed to the more common, lower-bar finding that it “may present an unreasonable risk” – involved residual isocyanates present after manufacture of two new chemicals.

In such cases EPA has imposed some combination of three types of conditions on manufacture of such chemicals:  prohibitions on activities that could generate inhalable forms of the chemical and result in inhalation exposures; strict requirements for the use of high-efficiency respirators and gloves; and a strict limit on the amount of isocyanate residuals allowed to be present in the new chemical, typically in the range of 0.1% to 0.2%.

So it is quite disturbing to see how EPA has dealt with the most recent such new chemical for which EPA has issued its final decision – which requires that companies employ NONE of these protections.  Read More »

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ACC and 1,4-dioxane: Its “late hit” tactics are just more of the same

By / Bio / Published: July 30, 2019

Richard Denison, Ph.D., is a Lead Senior Scientist.

The American Chemistry Council (ACC) was up to all of its old tricks yesterday at the first day of the Environmental Protection Agency’s (EPA) panel that is conducting a peer review of EPA’s draft risk evaluation of the likely human carcinogen, 1,4-dioxane.  We blogged last week about the extensive comments EDF submitted to the peer review panel on this flawed assessment.

Yesterday ACC rolled out the same game plan the industry has used for years to slow down, derail, or obfuscate chemical assessments conducted by EPA’s Information Risk Information System (IRIS), and more recently, the last Administration’s effort, now aborted by the Trump EPA, to restrict high-risk uses of the highly toxic chemical trichloroethylene (TCE).

In the public comment period yesterday afternoon, ACC Senior Director Steve Risotto revealed to the peer review panel that ACC has sponsored a new “study” that he says – lo and behold – supports all of the positions downplaying 1,4-dioxane’s carcinogenicity that ACC has espoused for years.

The aim of this is to get EPA to set the level of exposure to 1,4-dioxane that would be deemed acceptable well above the level EPA would set if 1,4-dioxane is assumed to pose a risk at any level of exposure.  (Briefly, if EPA determines that 1,4-dioxane does not have a safe threshold, it must extrapolate exposures to zero to set acceptable risk levels in its risk evaluation. If, as ACC wants, EPA finds that there is a threshold below which exposure poses no risk, then the Agency’s risk calculations will be much less conservative.)

So, where is ACC’s new study?  Well, it’s not public.  It hasn’t been provided to the peer review panel.  It hasn’t been published by ACC.  There’s no indication it’s been peer-reviewed.  Read More »

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The Trump EPA is setting back chemicals policies by decades

By / Bio / Published: June 13, 2019

Richard Denison, Ph.D., is a Lead Senior Scientist.


Tacoma, WA 1972

As we approach the third anniversary of the historic passage of bipartisan legislation to overhaul our nation’s broken chemical safety system, we’re hearing that political appointees at the agency are gearing up to celebrate their “successes” in implementing the law.

Even more disturbing than its individual actions are the methodical steps the Trump EPA is taking to dismantle decades of progress in our country’s chemicals policies.

While the chemical industry may well have things to celebrate, it’s simply not the case for the rest of us:  Comments from former top EPA officials, members of Congress, state and local governments, labor groups, firefighters, water utilities, public health groups, and a broad range of environmental groups make crystal clear that there’s nothing warranting celebration.  EPA’s actions are threatening the health of American families.

But as I reflect on how implementation of the Toxic Substances Control Act (TSCA) has gone off the rails under the Trump EPA, even more disturbing than its individual actions are the methodical steps it is taking to dismantle decades of progress in our country’s chemicals policies.  In this post, I’ll briefly highlight five such policies and how this EPA is undermining them:

  • Pollution prevention
  • Inherent safety and hazard reduction
  • Protection of vulnerable subpopulations and environmental justice
  • Holistic, real-world risk assessment
  • Public right to know

Read More »

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Company safety data sheets on new chemicals frequently lack the worker protections EPA claims they include

By / Bio / Published: May 22, 2019

Richard Denison, Ph.D., is a Lead Senior Scientist.

Readers of this blog know how concerned EDF is over the Trump EPA’s approval of many dozens of new chemicals based on its mere “expectation” that workers across supply chains will always employ personal protective equipment (PPE) just because it is recommended in the manufacturer’s non-binding safety data sheet (SDS).

How much farther under the bus will the Trump EPA throw American workers?

The typical course has been for EPA to identify risks to workers from a new chemical it is reviewing under the Toxic Substances Control Act (TSCA), but then – instead of issuing an order imposing binding conditions on the chemical’s entry onto the market, as TSCA requires – to find that the chemical is “not likely to present an unreasonable risk” and impose no conditions whatsoever on its manufacturer.  This sleight of hand is pulled off by EPA stating that it:

expects employers will require and workers will use appropriate personal protective equipment (PPE) … consistent with the Safety Data Sheet prepared by the new chemical submitter, in a manner adequate to protect them.

We have detailed earlier the myriad ways in which this approach strays from the law, is bad policy and won’t protect workers.  But here’s yet another gaping problem:  When we are able to look at the actual SDSs – that is, when EPA has made them available and when they are not totally redacted – we are frequently finding that the specific PPE that EPA claims to be specified in the SDSs – and that EPA asserts is sufficient to protect all workers handling the chemical – is not in the SDSs.   Read More »

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